Company profile

From the very beginning quality management and computerized system validation have been at the basis of our products and services offerings. Needless to say we are dedicated to life sciences and know the ins and outs of the industry.
With a team of highly skilled professionals we work closely together with our customers to establish the best possible information systems to support their business. Technical implementation, configuration, validation, training and operational support are with Iperion in one hand. The high customer satisfaction ratings underline the appreciation the market has for our expertise, drive and dedication. It is these characteristics that have also put Iperion on the forefront of cloud computing technology.

Our offerings encompass GxP compliant system hosting and provisioning of virtual private cloud solutions for life sciences companies, to IAAS and PAAS solutions for software vendors thus enabling them to offer SAAS solutions to the industry. Iperion provides these cloud computing solutions from self-owned and self-managed state-of-the-art data centers qualified according to US / EU GxP regulations as well as being ISO 27001 and ISO 9001:2008 certified.

Quality Policy

When providing products and services Iperion is committed to create a situation in which both customer and Iperion are satisfied with the delivery process and the end result. The quality policy is aimed at offering products and services that are verifiable and have the quality attributes as agreed with the customer. A continuous effort will be undertaken to comply with the requirements (customer requirements, industry standards as well as legal requirements) and improve the effectiveness of Iperion’s quality management system.
The delivery of high-quality services is the responsibility of Iperion’s management. All staff members create the contents of the quality policy when performing their daily tasks. Iperion management supports, stimulates and inspires staff members to adopt the quality attitude as a second nature. Management is committed to guide and to provide training as well as the means necessary to be able to execute the quality policy.

A plan will be made on a yearly basis in which quantifiable goals will be defined regarding:
* Customer satisfaction: our customer’s level of satisfaction with regard to the services delivered by Iperion;
* Project results: the percentage of projects (customer assignments) that have been executed within time and within budget;
* Learning organisation: the level of organisational ability to learn from experience and translate this into improvement.

Iperion is a dynamic, innovative and goal oriented organisation with a strong drive for customer success.

We are interested in employees with a high level of education, ambition, and creativity. We are always looking for people who are enthusiastic, smart, reliable, and looking for a place where their opinion and input is appreciated. If you are educated in IT, Pharmacy, Logistics, Supply Chain Management, or have a strong pharmaceutical background, please contact us to find out about employment possibilities. We have offices in Vlijmen, The Netherlands, in Lund, Sweden, and in Saarbrücken, Germany.

Young Pharma Professional ProgramTraineeship 0-5 years of work experience
Are you an ambitious and talented starter with a Bachelor or University degree?
Do you have affinity with both ICT as well as the pharma or life sciences?
Would you like to develop and make the most out of your professional and personal talents?
Do you want to jump start your (international) career?

Advanced Pharma Professional ProgramDevelopment program 5-15 years of work experience
Are you an experienced professional with a Bachelor or University degree?
Do you have experience in ICT as well as the pharma or life science?
Would you like to develop and make the most out of your professional and personal talents?
Feel something for a dynamic by start of your career?

Interested? Get in touch with us.
You can send your application letter, including your CV, via e-mailcontact us at +31(0)73 6488000.

Consultancy

Validation Consultancy

These days, research, development and manufacturing are largely dependent on computerized systems. The guidelines and legal standards that govern the life sciences industry specifies that these systems need to be validated. However, validation is not only a regulatory requirement; it is your only way of ensuring that your systems operate the way that they are supposed to.
To aid you in your effort to comply with government regulations and keep your IT-infrastructure adequately documented, we offer a start-to-finish solution for validating an information system according to GAMP5 (Good Automated Manufacturing Practice).
We use a risk based approach combined with tried and true example policies/templates to guide the validation process from planning to “go live”. Our approach is aimed at verifying that the system is fit for purpose. We make sure that all knowledge of how the system works is made explicit and documented and that policies and procedures are set up to maintain the system in a validated status.

Qualification IT infrastructure

Having all your critical applications in the GxP cloud, significantly reduces your local IT infrastructure. The remaining local IT infrastructure needs to be compliant with regulations set by authorities. Iperion offers consultancy and hands-on services for the installation, qualification and maintenance of the (remaining) local physical IT Infrastructure. Standard procedures and work instructions are in place to guarantee a safe, secure and compliant local IT Infrastructure. Training will be provided to the IT staff to ensure the qualified state.

IT consultancy services

IT consultancy services are related to business intelligence, strategic IT consulting, platform management and application management services. Iperion is committed to enhancing clients’ flexibility and operational simplicity, while improving their business and communication processes.

Gap analysis

Not sure if the current IT infrastructure complies with required regulation? Doubting whether the IT is secure and safe enough?
By having a Gap analysis the steps that are required to meet a desired situation will be clearly documented with a CAPA plan included. Possible topics for Gap analyses are security, compliance with regulations, and qualification analyses.

A single integrated solution specifically for the life sciences industry, based on Microsoft Dynamics ERP 2012.

GxP Cloud Computing

Iperion provides GxP cloud computing and private cloud infrastructure to the life sciences industry. Whether it concerns a single application or your complete IT infrastructure, we have the right solutions for your business needs.

For software vendors who offer their Software As A Service (SAAS) to the regulated industry we have the choice to utilise our facilities in the form of Infrastructure As A Service (IAAS) or Platform As A Service (PAAS). Both options are designed and built on proven technology thus enabling software vendors to deliver world class performance to their customers.

The Iperion cloud computing solutions are provided from self-owned and self-managed state-of-the-art data center facilities qualified according to US and EU GxP regulations, certified for ISO 27001 and ISO 9001:2008.

Dedicated to the life sciences industry.
Iperion is dedicated to the life sciences industry, we know the ins and outs of the trade, and understand the importance of being compliant. With a team of highly skilled professionals we work closely together with our customers in the pharmaceutical, biotechnology, medical device and health care domain to establish and maintain the best possible systems and infrastructure solutions.

Qualified IT infrastructure.
Iperion’s GxP cloud platform infrastructure is qualified in line with GAMP “Good Prac­tice Guide IT Infra­struc­ture and Compliance”. Additions and or modifications to either infrastructure or customer-dedicated environments are performed under stringent Change Control to secure qualified status. We apply advanced risk management techniques to identify, address and mitigate potential risks. Our infrastructure design and construction is robust and able to meet the high demands of our industry.

For a good reason the results of our customer audits are rated as excellent.

If you would like to know more about the technical specifications of our data center, infrastructure, connectivity and security, please download our product data sheet.

Support

When you have bought our services we commit ourselves to a long term rela­tion­ship and we want to add real value for you and your busi­ness. Having imple­mented and configured your sys­tem, it is log­i­cal to us that we also deliver the tech­ni­cal sup­port. We under­stand the impor­tance of the sys­tems to our cus­tomers and our sup­port team acts based on that knowl­edge.

We have the tools and equip­ment to allow fast and reli­able com­mu­ni­ca­tion, log­ging of inci­dents, mon­i­tor­ing of activ­i­ties, and prob­lem res­o­lu­tion. We work in close con­nection with our sys­tem suppliers in case soft­ware issues can­not be resolved by Iperion.

Professional Services

A dedicated team of trained system consultants are available to configure the information system up to the customer needs in a compliant and validated manner.

Our consultants are experienced in the following professional services:

Software Development

When a specific information system does not fulfill all the requirements, some additional software or interfaces can be created. Iperion engineers are experienced in a wide variety of platforms and systems and can assist the customer where needed.

System Configuration

Basis for the con­fig­u­ra­tion is the workshop(s) together with process own­ers and experts. Of course Iperion best prac­tices are integrated that are used to chal­lenge cus­tomers and have them bal­anced with their own prac­tices. In the end the agreed con­fig­u­ra­tion is doc­u­mented and for­mally approved.
This doc­u­ment is from that moment on vital for the organ­i­sa­tion as it details how the sys­tem is (going) to sup­port cus­tomers processes. At the same time it is the base line for sys­tem change con­trol and thus impor­tant from a val­i­da­tion stand point of view as well.

Training

Training services are provided at Iperion’s Training Centre or on–site at customer location.
We provide system specific training for system administrators, IT employees, expert users, and end users.

Our training programs are geared towards giving our trainees as much practical hands-on experience of the system as possible while being supported with the relevant background information. This allows the trainees to gain overall insight into how their tasks are supported by the system while acquiring the skills to execute their tasks in it.

Depending on a customer’s situation we are of course able to adapt our training program to align with company training needs.
Training services are provided at our Training Centre in Vlijmen, or on–site at customer location.

Data migration

When moving from one system to another there is bound to be a need for data migration.

Since the migration is part of the validation process we always perform a risk analysis. The outcome of that analysis determines how the migration is executed and which verification activities are required to guarantee the correct and complete transfer of data in the new system.

When possible we also encourage you to perform a clean-up activity to make sure only relevant and non-polluted data is being transferred. Finally, the migration of data is carefully prepared and documented in a separate document.

Validation

To ensure your Infor­ma­tion sys­tems com­ply with your qual­ity demands we will doc­u­ment and qual­ify them accord­ing to gov­ern­men­tal guide­lines and busi­ness stan­dards such as GAMP5 (Good Auto­mated Man­u­fac­tur­ing Prin­ci­ples).

MasterControl

“The only qual­ity man­age­ment sys­tem you will ever need to use”

Mas­ter­Con­trol is a global provider of Qual­ity Man­age­ment Soft­ware used by hun­dreds of com­pa­nies to stream­line their qual­ity man­age­ment processes to meet com­pli­ance. The core of the Mas­ter­Con­trol Suite is an inte­grated solu­tion offer­ing:

Doc­u­ments:

Mas­ter­Con­trol Doc­u­ments is the Doc­u­ment Man­age­ment Solu­tion that meets all your qual­ity and reg­u­la­tory com­pli­ance issues. Life­cy­cle man­age­ment, col­lab­o­ra­tion, MS word inte­gra­tion etc. are all fea­tures that makes Mas­ter­Con­trol doc­u­ments an easy to use Doc­u­ment Man­age­ment Sys­tem and in addi­tion it com­plies with FDA 21 cfr part 11.

Train­ing:

Mas­ter­Con­trol Train­ing is a Train­ing Man­age­ment Solu­tion that tracks, auto­mates and man­ages employee train­ing records. With Mas­ter­Con­trol Train­ing you are always ensured that the train­ing cur­ricu­lum of your employ­ees is up to date and reportable. Mas­ter­Con­trol Train­ing works together with Mas­ter­Con­trol Doc­u­ment so that if e.g. a SOP revises your asso­ci­ated “read and under­stood” courses are fired off auto­mat­i­cally to ensure com­pli­ance.

Process:

Mas­ter­Con­trol Process auto­mates all of your com­pa­nies (Qual­ity) Form processes. Whether it’s a CAPA, Devi­a­tion Batch Record or Change Con­trol Mas­ter­Con­trol can auto­mate this process either in HTML or a PDF form. Fur­ther­more an easy to use pack­age of ready to use best prac­tice solu­tion pack­ages are avail­able for all com­mon GxP Processes. If the stan­dard is not suf­fi­cient IPERION’s indept GxP process exper­tise can help you to cre­ate and auto­mate your cus­tom process in Mas­ter­Con­trol.

Inte­gra­tions / Inter­face:

All core mod­ules can be used inde­pen­dent or used together as an inte­grated Qual­ity Man­age­ment Sys­tem. This flex­i­bil­ity ensures a future proof solu­tion, since enabling other mod­ules does not require cus­tom programming/ exten­sive change man­age­ment.

IPERION is a fully cer­ti­fied and full ser­vice Mas­ter­Con­trol Part­ner.

We offer Mas­ter­Con­trol Instal­la­tion, Con­fig­u­ra­tion, Val­i­da­tion, Tech Sup­port, and Train­ing Ser­vices. The full Mas­ter­Con­trol Suite can also be hosted by IPERION. Read more about Life sci­ences and GxP Host­ing. Please con­tact Iperion or visit Mas­ter­Con­trol for more infor­ma­tion regard­ing Mas­ter­Con­trol.

DocuBridge

LORENZ’s docuBridge is the state of the art sub­mis­sion man­age­ment tool rec­og­nized by both life sci­ences com­pa­nies and review­ing agen­cies through­out the world.

LORENZ’s docuBridge has the fol­low­ing fea­tures:

Submission Management by design

LORENZ docuBridge was designed from the ground up as a sub­mis­sion man­age­ment sys­tem, not merely an eCTD pub­lish­ing tool. As a result, cus­tomers can lever­age the exist­ing sys­tems and processes for newly evolv­ing e-submission stan­dards. LORENZ always focuses on process over for­mat when design­ing prod­ucts.

Inter­na­tional in Scope

LORENZ docuBridge is a tried and tested sys­tem in over twenty coun­tries with many thou­sands of e-submissions to its credit. As a result, LORENZ is well aware of the var­i­ous inter­pre­ta­tions of the ICH guide­lines, as well as vary­ing val­i­da­tion rules that each coun­try and/or region devises for itself. This knowl­edge is reflected in prod­uct design and func­tion­al­ity.

Doc­u­ment Management System

LORENZ docuBridge can link up to any num­ber of dif­fer­ent Doc­u­ment Man­age­ment Sys­tems (DMS) in par­al­lel. Cur­rently, LORENZ docuBridge has drag-and-drop con­nec­tors to EMC Doc­u­men­tum, Mas­ter­Con­trol, Microsoft Share­point, NextDocs, Open­Text Livelink, Qumas Doc­Com­pli­ance and SAP ERP. Con­nec­tions can be made to fur­ther Doc­u­ment Man­age­ment Sys­tems via LORENZ’ pro­pri­etary reg­Doc soft­ware.
In addi­tion, LORENZ docuBridge oper­ates rel­a­tively inde­pen­dently from DMS upgrades. This min­i­mizes efforts on either side when upgrad­ing a full DMS or when upgrad­ing LORENZ docuBridge.
For those com­pa­nies with­out a corporate-wide DMS, LORENZ docuBridge bun­dles a 21 CFR Part 11 com­pli­ant DMS that allows all types of com­pa­nies to work in com­pli­ance.

Advanced lifecycle management

LORENZ docuBridge sports the most advanced Life Cycle Man­age­ment engine with ver­sion V. The solu­tion is based on LORENZ’ own Real Time Doc­u­ment & Sub­mis­sion Pro­cess­ing Frame­work. Among other ben­e­fits, it allows LORENZ to use its own method­ol­ogy to man­age the life­cy­cle. This reduces the risk of non­com­pli­ance as stan­dards change. It also adds func­tion­al­ity to an oth­er­wise more lim­ited life­cy­cle man­age­ment con­cept as defined by the eCTD. LORENZ docuBridge’s life­cy­cle man­age­ment con­cept can thus be applied across stan­dards, sig­nif­i­cantly increas­ing the value of the work put into com­pil­ing e-submissions for later re-use.

Performance and scalability

LORENZ docuBridge V takes another giant step in terms of per­for­mance and scal­a­bil­ity. Work­loads can be dis­trib­uted across mul­ti­ple servers, allow­ing tasks to be paused and resumed or even redi­rected which is par­tic­u­larly impor­tant if faced with hard­ware fail­ure. Addi­tion­ally, a new sub­mis­sion access method­ol­ogy increases per­for­mance dra­mat­i­cally when in life­cy­cle mode.
In lab­o­ra­tory envi­ron­ments, with­out dis­trib­ut­ing tasks in par­al­lel to mul­ti­ple servers, LORENZ has already achieved pub­lish­ing speeds of over 15,000 pages per minute. This makes LORENZ docuBridge V the fastest pub­lish­ing sys­tem in its class.

Paper and electronic compliance

Paper is still a require­ment in most coun­tries. Cus­tomers do not need to cre­ate dif­fer­ent sub­mis­sions for their paper and elec­tronic processes. Through the use of the real-time frame­work, it is easy to uti­lize the same sub­mis­sion for the paper as well as the elec­tronic out­put. Over­lay infor­ma­tion reg­u­lates the dif­fer­ent views a user may have, but no changes are made to the con­tent of the sub­mis­sion itself.

IPERION is a reseller of LORENZ’s prod­ucts. Con­tact us if you would like to receive more infor­ma­tion about LORENZ’s prod­ucts.

PhRISMA

If you work in the life sci­ences indus­try you must always remain in com­pli­ance with reg­u­la­tions
set by gov­ern­ments all around the world . To accom­plish this with the con­stantly chang­ing envi­ron­ment of sci­ence research your reg­u­la­tory infor­ma­tion must be vis­i­ble and easy to acces­si­ble
in each depart­ment within your orga­ni­za­tion.

PhRISMA

With PhRISMA you are able to link data from all your ERP sys­tems (Enter­prise Resource Plan­ning) with reg­u­la­tory data man­age­ment sys­tems. This enables you to view the spe­cific reg­u­la­tory require­ments that is involved for each spe­cific process and depart­ment that you are work­ing with. Help­ing you to avoid mis­takes, reduce costs and shorten time-to-market.

Phrisma pro­vides:

Reg­u­la­tory track­ing;

Reli­a­bil­ity: guar­an­teed con­sis­tency between data;

Global, Real time per­mis­sion– based vis­i­bil­ity;

Rapid access to infor­ma­tion of reg­is­tra­tion require­ments.

Project Man­age­ment

Thanks to the inte­gra­tion between dif­fer­ent sys­tems you are able to match dif­fer­ent types of data and com­bine them with busi­ness logic and algo­rithms. In addi­tion you will have a bet­ter insight in your com­pany processes with the help of the plan­ning and fore­cast­ing mod­ule.

Sup­ply Chain Man­age­ment

Another area where reg­u­la­tory data inte­gra­tion with your other ERP sys­tems pro­vides you with the pos­si­bil­ity to make pre­med­i­tated deci­sions is within sup­ply chain man­age­ment.

With the PhRISMA solu­tion you are able to:

iden­tify bot­tle­necks in the process;

offer a real time insight of cur­rent and planned sta­tus activ­i­ties;

AX for Pharma

AX for Pharma product & services.

AX for Pharma is a fully integrated ERP solution designed to meet the specific requirements for the Pharmaceutical Industry. At the basis is the Microsoft Dynamics AX 2012 software that allows companies of all sizes to manage their entire business processes, including supply chain, procurement, human resources, financials, and projects.

The AX for Pharma solution consists of a number of modules that enhance the MS Dynamics AX 2012 and makes it the ultimate Pharma solution.
The module Basic Pharma covers functionality that ensures the system is compliant with regulatory requirements and GxP guidelines regarding traceability, electronic signatures and user authorisations. Also included are a number of features that in the past required considerable customisations e.g. handling of unapproved items, sub batch tracking and qualification status on vendor/manufacturer.

The modules Dispensing, GMP Plant Maintenance and Activity-Based Costing complete the list of functionality areas that makes life much more easy being integrated into a single AX solution. Add to that the fact that an extensive validation package is available, in support of a simplified and cost effective system validation, and you understand that Iperion delivers a high quality, world class performing information system ensuring total peace of mind.

Because AX for Pharma is built entirely on the Microsoft technology stack, taking advantage of Dynamics AX, SQL Server, SharePoint and Office, all processes are seamlessly integrated.
This 100% integrated solution allows all the functionality needed for the specialized Pharmaceutical business, without the need to purchase any additional software for specialized tasks.
AX for Pharma provides a modern solution that offers industry-specific functionality, increases compliance and simplifies computer system validation.

Dedicated to the life sciences industry.

Iperion is dedicated to the life sciences industry, we know the ins and outs of the trade, and understand the importance of being compliant . With a team of highly skilled professionals we work closely together with our customers in the Pharmaceutical, Biotech, Medical Device and Health Care domain to establish and maintain the best possible systems and infrastructure solutions.
Both excellent results on compliance audits as well as high customer satisfaction ratings underline the appreciation the market has for our expertise, creativity and drive.

Are you also looking for total peace of mind?
Call Iperion and ask for a demo. Find out what AX for Pharma can mean for your business!

Iperion announces partnership with CluePoints

Vlijmen, 15 December 2014

IPERION, a leading provider of information systems, cloud computing and consultancy services for the Life Sciences industry and CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, announced a partnership with CluePoints.
The new CluePoints® SAAS software solution will run in a specific CluePoints private cloud computing environment within Iperion’s GxP compliant datacenter. This way, the data integrity and quality can be guaranteed.

CEO of IPERION invited to speak at the ECA GMP Course March 2015

CEO Karel Bastiaanssen will give 2 presentations at the ECA GMP Course Cloud Computing and Outsourcing in a GxP Environment. The course will take place 12-13 March in Berlin, Germany where the following topics will be highlighted:
The cloud service provider business & Operating as a Cloud Service Provider.

IPERION CEO speaker at the LORENZ userBridge.14 Conference

Karel Bastiaanssen, CEO of IPERION Life Sciences Group, has been invited to speak at the LORENZ userBridge.14 Conference, 23-25 September in Milan, Italy.
IPERION will take the attendees into the world of “Cloud Computing For Life Sciences - What Is There To Know.”

IPERION attends meeting at the European Compliance Academy

“We are excited about the partnership between CluePoints and IPERION, says Karel Bastiaanssen, CEO of IPERION. Partnering with CluePoints will strengthen our position as a major player in the industry and will support our long-term strategy for global presence. With our expertise on compliance and technology we are able to support customers and provide the market the necessary tools to fulfill a specific need. Furthermore, our datacenter is full compliant and self-managed which gives us the opportunity to be flexible and fast.

"We have chosen IPERION because of their expertise of the GxP cloud computing market and their robust and fast infrastructure. Our main requirement was to have servers qualified in line with GAMP and certified ISO 27001 and ISO 9001:2008, says Erik Doffagne, Product Manager of CluePoints."

The Iperion cloud computing services support companies that are looking to expand business but at the same time also have to standardize and incorporate new technologies. The market for GxP cloud computing needs standardization of service expectations while still allowing the flexibility that the industry demands.

About Iperion
With more than 3 decades of experience in the life sciences industry, IPERION® has been recognized for its dedication in quality management and delivery of high quality systems & services in life sciences.
The company is specialized in information systems, consultancy and GxP Cloud Computing that ensure compliance. IPERION® operates in the pharmaceutical, medical devices, biotechnology and health care sectors. The head office is located in Vlijmen, the Netherlands and its facilities are established in both Europe and the US.
IPERION® serves its customers to fulfill the high demand to acquire the best available, custom-made information system that integrates processes and industry standards. Furthermore, data security and data integrity is the focus for our GxP cloud computing solutions when it comes to information technology. IPERION® is ISO27001 and ISO 9001:2008 certified.

Objectives
Get to know the different types of cloud computing, their technical basics and their validation approaches. What are the pharmaceutical authorities’ requirements with regard to cloud computing and what regulations have to be observed? An inspector will present his perspective to these questions and the experience gained so far in audits and will further cover critical points.
You can assess the use of cloud computing from the perspective of IT security and data protection rules, and based on that you can formulate requirements for cloud service providers. You can evaluate the opportunities and risks of cloud computing in the GxP environment.

Karel Bastiaanssen, CEO of IPERION Life Sciences Group, has been invited to speak at the LORENZ userBridge.14 Conference, 23-25 September in Milan, Italy.

The presentation: “Cloud Computing For Life Sciences - What Is There To Know” provides insight in how cloud computing can be utilized within the GxP regulated environment. What is different to traditional IT infrastructure usage and how this impacts your compliance requirements.

The annual LORENZ user conference is one of the most educational events in e-regulatory affairs globally, bringing together both industry and agency perspectives in one gathering. The conference has become an annual occasion for anyone interested in the digitization of regulatory affairs. UserBridge is synonymous with education and information exchange on the highest level. The event also offers an ideal setting for doing business.

IPERION will attend a meeting of the European Compliance Academy: Virtual IT-Systems in a GxP Environment on 17-18 September in Prague, Czech Republic.

- Get an overview of technologies discussed currently in the pharmaceutical environment and their potential fields of application.
- Assess how to use and implement GMP requirements and provisions for virtual IT systems and, where appropriate, for cloud computing,
- Learn more about the qualification and use of virtual systems in the GMP environment.

Iperion is specialised in information systems, GxP cloud computing and consultancy for companies operating in the life sciences industry. We use our knowledge, creativity and drive to deliver successful solutions supporting our customers business. As one team, our highly skilled professionals work closely together with our customers delivering high quality, world class performing information systems and infrastructure technology, ensuring total peace of mind. Both excellent results on compliance audits as well as high customer satisfaction ratings underline the appreciation the market has for our approach.

Contact

Benelux Office

IPERION IS B.V.

Achterstraat 27

5251 CS Vlijmen

The Netherlands

+31 (0)73 6488000

Nordic Office

IP Life Sciences AB

Scheelevagen 15

223 70 Lund

Sweden

+46 (0)46 2868770

German Office

Iperion GmbH

Albertstrase 1

66265 Heusweiler

Germany

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